Framework

The Johns Hopkins University Proposed Ethical Framework

At a time when this sort of change is very much needed, an ethics framework for a learning healthcare system has not been previously articulated. Our framework departs from the current, dominant bioethics paradigm by positing that research and practice can and should be integrated.

We have outlined our moral framework and questions to ask oneself when integrating this framework within their study or health system:

1. RESPECT THE DIGNITY AND RIGHTS OF PATIENTS

Respecting the dignity of patients requires health profession­als to express respectful attitudes and to treat patients as hav­ing an inherent moral worth by, for example, helping patients understand what is happening to them and following the lead of patients in involving their families and friends in their care.

Questions to consider around this obligation

How does a learning activity impact patients’ rights, respectful treatment, and dignity?

2. RESPECT THE JUDGMENT OF CLINICIANS

We use the term “judgment” broadly to mean the clinician’s considered beliefs about how best to care for a patient in light of multiple considerations and influ­ences, including personal professional experience, the experi­ence of colleagues and mentors, scientific evidence, and the clinician’s understanding of the patient’s values and priorities. However, one problem with the obligation to respect clinician judg­ments is that even the most well-intentioned judgments of clinicians can be subject to some form of bias.23 A key precept of evidence-based medicine is that clinician judgment may not result in the best health outcomes for patients, especially when there is an absence of good empirical evidence or that evidence does not factor in the forming of the judgment. When learning activities target areas in which there is clinical uncer­tainty about best practices or limited empirical evidence, the likelihood that unrestricted clinician judgment will advance the health interests of patients is lessened, and the importance of respecting clinician judgment is weakened.

Questions to consider around this obligation

How does a learning activity impact a clinician’s ability to use his/her own judgment?

3. PROVIDE EACH PATIENT WITH OPTIMAL CLINICAL CARE

A central moral consideration in assessing the ethical acceptability of a learning activity is how the expected net clinical benefit for the patients affected by a learning activity compares to the net benefit they likely would have experi­enced if their care had not been affected by that activity.

Questions to consider around this obligation

How will a learning activity impact the net clinical benefit to patients compared to benefits from “ordinary care” without a learning activity?

Does “learning” make the care any riskier for patients?

Will patients be worse off?

4. AVOID IMPOSING NONCLINICAL RISKS OR BURDENS

The impact of a learning activity in imposing nonclini­cal risks and burdens—in comparison to the nonclinical risks and burdens that the patients could be expected to experience if their clinical care did not involve the learning activity— is a moral consideration.

Questions to consider around this obligation

What other non-clinical risks and burdens do patients experience?

How do these compare to those likely from “ordinary care” outside of a learning activity?

Are there any additional burdens for patients because the “learning activity” is happening?

5. ADDRESS UNJUST HEALTH INEQUALITIES

The learning health care system ethics framework also imposes an affirmative obligation to direct learning activities toward ag­gressive efforts to reduce or eliminate unfair or unacceptable inequalities in the evidence base available for clinical decision-making, in health care outcomes, and in the respectfulness with which health care is delivered. The nar­rowing of inequalities and the elimination of discrimination in care between minority and majority patients, economically impoverished and economically secure patients, and poorly educated and well-educated patients is a national priority in the United States and in many other countries.29 Our framework requires that learning activities be assessed to determine whether they perpetuate or exacer­bate unjust inequalities and to determine whether they can be structured to advance the goal of reducing or eliminating inequalities and discrimination in health care. This role has not traditionally been at the forefront of the list of obligations of health care institutions, where these problems of unjust inequalities have been widely overlooked.

The obligation re­quires that every practitioner and institution accept a respon­sibility to feed information into the system that increases our knowledge. Each learning activity to be conducted within the system must be individually assessed for the extent to which it holds out the prospect of contributing to the improvement of health care services and systems.

Questions to consider around this obligation

How will the health system educate and inform providers about the benefits of a continuous learning healthcare system?

7. CONTRIBUTE TO THE COMMON PURPOSE OF IMPROVING THE QUALITY AND VALUE OF CLINICAL CARE AND HEALTH SYSTEMS

Who is responsible of obligation 7?

Patients

A learning health care system must have continuous access to information about as many patients as possible to be efficient, affordable, fair, and of highest quality. In proposing that patients have an obligation to contrib­ute to the common purpose of improving health care through learning, we are not proposing that patients have an affirma­tive moral obligation to participate in all learning activities regardless of the degree of additional risk or burden they may impose. Different learning activities will have differential ef­fects on the rights and interests of patients and therefore will have different implications for patients’ obligations to par­ticipate in them.

Questions to consider around this obligation

How would a health system describe a learning healthcare system to their patient population?

Do patients have an obligation to participate in ALL learning activities?